NFIX II PEDICLE SCREW SYSTEM

Posterior Metal/polymer Spinal System, Fusion

N SPINE, INC.

The following data is part of a premarket notification filed by N Spine, Inc. with the FDA for Nfix Ii Pedicle Screw System.

Pre-market Notification Details

Device IDK061774
510k NumberK061774
Device Name:NFIX II PEDICLE SCREW SYSTEM
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant N SPINE, INC. 13221 MARICOTTE PLACE San Diego,  CA  92130
ContactR. Stephen Reitzler
CorrespondentR. Stephen Reitzler
N SPINE, INC. 13221 MARICOTTE PLACE San Diego,  CA  92130
Product CodeNQP  
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2006-06-23
Decision Date2006-12-13
Summary:summary

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